Research

How to Start a Research Project

Maybe you are interested in conducting research but you aren’t sure what you’d like to focus on, what is feasible, or how to go about it. Use these tips to help you get started. 

Form a research question, or at least a general idea of what you are interested in.

  • Do some preliminary research on your general topic and a few quick searches to see what scholars and researchers are saying about your topic. What questions come up for you as you read these articles?
  • Talk with our librarians! Set up a research consultation meeting with the PNWU Library. Our librarians are incredibly knowledgeable about knowing where to find information, making sure information is credible, and narrowing down your research question.

Speak with faculty, staff, and other students

  • Speak with faculty and ask them about projects they’ve worked on, how their projects got off the ground, what kinds of projects are feasible for a student, and if they are looking for help from students currently.  
  • Talk to other students. Some can clue you in on the research process and some might be able to include you in their own project.

Talk with the Office of Scholarly Activity

Contact the Office of Scholarly Activity for Statistical Consultation

What is “Research?” Is Your Project Considered Research?
Determining whether or not a project meets the federal definition of human subjects research is a two-step process. It must first be determined if the project meets the federal definition of research, and if so, then if the project includes human subjects.

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Systematic investigation: A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan.

Generalizable knowledge: The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

  • Results that are applicable to a larger population beyond the specific subjects studied or the site of data collection
  • Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

If your potential research activities include developing information about a drug, medical device, or biologic substance, please contact the Institutional Review Board at research@pnwu.edu.

Office of Human Research Protections (OHRP) Human Subject Regulations Decision Charts

Certain activities are considered not to be research, including the following:
  1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Research with Human Subjects
Any research or scholarly activity that may involve human subjects must go through the Institutional Review Board (IRB) for either determination or approvalDetermination is the process of deciding if your project involves human subjects. If your project is determined to be research on human subjects, then you will need further approval from the IRB. 

Pacific Northwest University does not allow investigators to make their own determination if their research/scholarly activity involves human subjects. This page gives an overview of what human subjects are and what result you might expect from the IRB.  Reach out to the Institutional Review Board at research@pnwu.edu. 

human subject is a living individual about whom an investigator (whether professional or student) is conducting research:

  1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Certain research activities on human subjects that go through the IRB for determination but not for approval include:
  • Class Projects, Research Practices, and Undergraduate Thesis Projects involving research methodology and course-assigned data collection. These activities generally do not constitute research because they are designed to provide training in research as part of the overall educational mission of a program and are not intended to contribute to new knowledge.
  • Quality Assurance/Quality Improvement Programs that attempt to measure the effectiveness of programs or services, including program evaluations, model curriculum, or needs assessments. Such activities are not typically designed to be generalizable to the larger community and would not be considered research if results will not be compared with other assessments. Those responsible for such projects must be certain that the activities are not human subjects research and should contact the IRB if in question.
  • Case Reports/Case Series (equal to or less than 4 subjects) utilizing private identifiable information such as medical information collected from a clinical activity. Case reports are generally carried out by retrospective review of records and highlight a unique treatment, case, or outcome. As the collection and organization of information for such reports usually involves no data analysis or testing of a hypothesis, they do not constitute a systematic investigation. Therefore, single case reports/series would not require IRB review. 
  • Research on Institutions or Social Processes when the intent or focus of the research is to gain knowledge of an institution or social process (e.g., political party or labor negotiations) and this research is not intended to generate generalizable knowledge about any particular individual or groups of individuals. Often, investigators wish to collect information from individuals about institutions or social processes. Such activities are not considered human subjects research when the focus of the research is not on characteristics of an individual or groups of individuals because the information collected from the informant is not about the informant.

Office of Human Research Protections (OHRP) Human Subject Regulations Decision Charts

Example activities typically subject to human research protection:

  • Training programs in which individual training projects remain to be selected, randomized, or designed. 
  • Research, pilot or developmental studies in which the involvement of human subjects depends on such things as the completion of survey instruments or prior animal studies. 
  • Institutional Support Programs where the selection of the project is the responsibility of the institution or program administrator.
  • When supporting agencies require review and certification for such programs, protocols are to be submitted to the IRB with as much information as is available.
  • Masters Theses/Doctoral Dissertation involving human subjects.
  • Pilot Studies involving human subjects.
  • Clinical Investigations including research to increase scientific understanding about normal or abnormal physiology, disease states or development and research to evaluate the safety, effectiveness, or usefulness of a medical product, drug, device, procedure, or intervention. Vaccine trial, medical device research, and cancer research are all types of clinical investigation.
  • Behavioral and Social Science Studies such as investigations on individual and group behavior, mental processes, or social constructs. These usually generate data by means of surveys, interviews, observations, studies of existing records, and/or experimental designs involving exposure to some type of stimulus or environmental intervention.
  • Epidemiological Studies such as investigations on health outcomes, interventions, disease states, and conclusions about cost-effectiveness, efficacy, efficiency, interventions, or delivery of services to affected populations. This research may be conducted through surveillance, monitoring, and reporting programs. Other methods may include retrospective review of medical, public health, and/or other records. This includes meta-analysis of multiple case reports and retrospective record reviews that incorporate data collection and analysis.
Where Can I Find IRB Forms?

Institutional Review Board submissions are completed using Mentor IRB, a web based software program.

Mentor IRB uses single sign on (Login required). The institutional ID is PNWU. For questions or to schedule one-on-one training, please contact the IRB Administrator at Research@pnwu.edu or (509) 249-7852.

Software Links

CITI Training Program – Human Subject Protections Training (Login required)
Mentor IRB (New Software) – IRB Application Software (Login required)
REDCap – secure web application for building research databases, forms, and surveys (Login required)
Zotero – Free Citation Management Software

Investigator Toolbox (Login Required)

The Investigator is a collection of modifiable form templates that can be used for human subject research. The investigator toolbox can be accessed through Mentor IRB (Login required)

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